---
kind: "section"
citation: "21 C.F.R. § 630.1"
title: "21"
number: "630.1"
heading: "Purpose and scope."
url: "https://uscodex.org/cfr/21/630.1"
---

# §630.1. Purpose and scope.

- (a) **What is the purpose of subparts A, B, and C of this part—** ? The purpose of these subparts, together with §§ [610.40](/cfr/21/610.40.md) and [610.41](/cfr/21/610.41.md) of this chapter, is to provide certain minimum criteria for each donation of blood and blood components, for:
  - (1) Determining the eligibility of a donor of blood and blood components;
  - (2) Determining the suitability of the donation of blood and blood components; and
  - (3) **Notifying a donor who is deferred from donation.**
- (b) **Who must comply with subparts A, B, and C of this part—** ? Blood establishments that manufacture blood and blood components, as defined in § [630.3(a)](/cfr/21/630.3.md?p=a) and [(b)](/cfr/21/630.3.md?p=b), must comply with subparts [A](/cfr/21/subpartA.md), [B](/cfr/21/subpartB.md), and C of this part.

## Notes

### Source

Source: 80 FR 29898, May 22, 2015, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371; 42 U.S.C. 216, 262, 264.

### Source

Source: 66 FR 31176, June 11, 2001, unless otherwise noted.